U.S. patent application number 11/822793 was filed with the patent office on 2008-01-17 for methods and articles for treatment of rectal prolapse.
This patent application is currently assigned to AMS Research Corporation. Invention is credited to Richard C. Kaleta, Jason W. Ogdahl.
Application Number | 20080015614 11/822793 |
Document ID | / |
Family ID | 38950223 |
Filed Date | 2008-01-17 |
United States Patent
Application |
20080015614 |
Kind Code |
A1 |
Kaleta; Richard C. ; et
al. |
January 17, 2008 |
Methods and articles for treatment of rectal prolapse
Abstract
Improved methods and devices for treatment of rectal prolapse
are provided. A suturing console for suturing the rectal fascia at,
to, or about the sacral vertebral fascia is disclosed. A method of
repairing prolapsed rectum via a vaginal incision or perineal
incision is also disclosed.
Inventors: |
Kaleta; Richard C.;
(Plymouth, MN) ; Ogdahl; Jason W.; (Minneapolis,
MN) |
Correspondence
Address: |
AMS RESEARCH CORPORATION
10700 BREN ROAD WEST
MINNETONKA
MN
55343
US
|
Assignee: |
AMS Research Corporation
Minnetonka
MN
|
Family ID: |
38950223 |
Appl. No.: |
11/822793 |
Filed: |
July 10, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60819371 |
Jul 10, 2006 |
|
|
|
Current U.S.
Class: |
606/144 ;
606/197; 606/222 |
Current CPC
Class: |
A61B 17/06109 20130101;
A61B 2017/06042 20130101; A61B 17/0483 20130101; A61B 2017/00398
20130101; A61B 2017/06009 20130101; A61B 2017/06076 20130101 |
Class at
Publication: |
606/144 ;
606/197; 606/222 |
International
Class: |
A61B 17/04 20060101
A61B017/04; A61B 17/06 20060101 A61B017/06; A61M 29/00 20060101
A61M029/00 |
Claims
1. A method for treating rectal prolapse in a patient comprising
the steps of reducing a prolapsed rectal tissue to an appropriate
location, making a vaginal or perineal incision to provide access
to a peritoneal cavity, attaching said rectal tissue at or to at
least one sacral vertebrae.
2. The method of claim 1, wherein the vaginal incision comprises a
posterior vaginal incision.
3. The method of claim 1, further comprising a step of identifying
the sacrum and coccyx prior to attaching said rectal tissue at or
to at least one sacral vertebrae.
4. The method of claim 3, wherein said sacrum and coccyx are
identified by digital rectal palpation.
5. The method of claim 1, wherein said attaching said rectal tissue
at or to at least one sacral vertebrae is via a suturing
device.
6. The method of claim 1, wherein said attaching said rectal tissue
at or to at least one sacral vertebrae comprises attaching a rectal
fascia to a fascia of said sacral vertebrae.
7. The method of claim 1, wherein said attaching said rectal tissue
at or to at least one sacral vertebrae comprises at least one of
attachment between the first and second sacral vertebrae,
attachment between the second and third sacral vertebrae, and
attachment between the fourth and fifth sacral vertebrae.
8. The method of claim 1, wherein said reducing a prolapsed rectal
tissue to an appropriate location comprises rectal insertion of a
device shaped in the natural geometry of the rectum.
9. A device adapted for reducing a prolapsed rectal tissue,
comprising a rubber mass shaped in the natural geometry of the
rectum.
10. A suturing device adapted for attaching a rectal tissue at or
to at least one sacral vertebral tissue.
11. The suturing device of claim 10, comprising: a needle adapted
to be placed between a rectal tissue and a sacrum or coccyx, said
needle comprising a handle at a first end, and a blunt tip portion
at a second end, and a suture console located relatively near the
blunt tip portion of said needle.
12. The device of claim 11, wherein said suture console comprises
an outer spring, and a suture with an attached sharp needle.
13. The device of claim 12, wherein the outer spring includes
troughs.
14. The device of claim 12, wherein the device includes a mechanism
adapted to activate the suture with sharp needle.
15. The device of claim 12, wherein said handle comprises controls
for activating said suture with sharp needle.
16. The device of claim 12, wherein said outer spring is
retractable.
17. The suturing device of claim 10, comprising a rectal tool
comprising: a handle, and an attached housing structure shaped and
sized as appropriate for urogenital surgery.
18. The device of claim 17, wherein said housing structure
comprises suture with a detachably connected sharp spring-like
needle, said suture and connected needle being at least partially
enclosed within said housing structure.
19. The device of claim 18, wherein the handle comprises a
mechanism for control of the activation of the enclosed suture and
attached needle.
20. The device of claim 18, further comprising a removable anchor
disposed on an end of the suture and detachably connected to the
spring-like needle.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This patent application claims priority to U.S. Provisional
Application No. 60/819,371, filed Jul. 10, 2006, the entire
contents of which are herein incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to urogenital and gastroenteric
surgery.
[0004] 2. Description of the Related Art
[0005] Rectal prolapse, in its most common form, is a condition in
which the rectum, the most distal portion of the colon, protrudes
from the anus. In fact, three different clinical entities are often
called rectal prolapse. These include full-thickness rectal
prolapse, mucosal prolapse, and internal prolapse (also known as
internal intussusception). The treatment of each is different.
[0006] Full thickness prolapse is the most commonly recognized type
of rectal prolapse, in which the full thickness of the rectal wall
protrudes through the anus. In mucosal prolapse, only the rectal
mucosa protrudes. Internal intussusception is a similar condition,
but the prolapsed tissue does not extend beyond the anus.
[0007] Rectal prolapse is considered uncommon, but the true
incidence is not known due to underreporting. Eighty to ninety
percent of patients are women, and peaks in occurrence are seen in
the fourth and seventh decades of life. Certain genetic or
chromosomal abnormalities, such as cystic fibrosis, have been seen
to result in increased incidence of rectal prolapse in
children.
[0008] As a condition predominately affecting women, rectal
prolapse is often concurrent with prolapse of other pelvic floor
organs. The etiology is not clear. Chronic straining during
defecation, hereditary factors, and stresses due to childbirth have
been implicated, as have the normal changes in the strength of
pelvic and anal sphincter muscles seen with aging, neurological
disease, and previous gastrointestinal or urogenital surgery.
Long-standing hemorrhoidal disease is also thought to lead to
certain types of rectal prolapse.
[0009] Clinically, a rectal prolapse begins as a mass protruding
from the anus only after a bowel movement which retracts when the
patient stands. If the disease progresses, it eventually reaches a
point where it protrudes in other situations, such as sneezing and
walking, and reaches a point where it does not spontaneously
retract. At this point, the patient may manually replace the mass.
Eventually, the mass may continue prolapsing immediately after
replacement. The rectum may become incarcerated, or ulcerated, and
it may be painful. Incontinence is seen due to interruption of the
normal function of the anal sphincter. In addition, the exposed
mucosa of the rectum constantly secretes mucous. Bleeding is
commonly seen. Trauma and strangulation of the protruded mass are
possible.
[0010] Rectal prolapse is generally diagnosed by physical
examination. Barium studies may be indicated, as may sigmoidoscopy,
to assess the rectum for additional lesions, such as tumors or
ulcers.
[0011] In young patients, conservative treatment with stool
softeners and suppositories. However, in adults, these medical
treatments are not generally effective, and surgery is
indicated.
[0012] Full thickness prolapse is treated surgically. One common
surgical technique is a sigmoid resection and rectopexy. In this
procedure, a portion of the colon is removed, and the remaining
portion of the rectum is anchored to the sacrum.
[0013] Various options are available for the rectopexy. The
Ripstein procedure incorporates the use of a nonabsorbable
material, such as a Marlex mesh, to augment the fixation to the
presacral fascia. The mesh stimulates scarring that serves to hold
the rectum in place. A similar process using suture instead of a
mesh material is also known.
[0014] This procedure involves an abdominal surgical approach, and
can be performed via laparatomy or laparoscopy. Compared to other
surgical options, abdominal procedures have a lower recurrence
rate, but higher morbidity. Further, abdominal approaches result in
scarring from the healing of abdominal incisions.
[0015] Other surgical procedures are known, including perineal
approaches. Several alternatives are available, including perineal
protectomy. Also known as the Altemeier Procedure, the surgeon
removes the prolapsed portion of the rectum via an incision in the
protruding rectum. Other perineal methods include anal
encirclement, which is essentially only palliative due to
complications such as chronic constipation. The Delorme mucosal
sleeve resection is a perineal approach often used for small
prolapses. Compared to the abdominal approach, perineal approaches
have higher recurrences, but lower morbidity.
[0016] Presently available methods of treatment are not without
problems. The recurrence rate for anterior resection without sacral
fixation is about 7-9%, with a morbidity rate of 15-29%.
[0017] For a rectopexy without resection, the recurrence rates
range from 2-10%, with morbidity rates of 3-29%. Unfortunately,
continence is only improved in 50-70% of patients, and constipation
may actually worsen.
[0018] When a resection is combined with a rectopexy, the
recurrence rate is reduced to about 3-4%. Morbidity ranges from
4-23%. Constipation improves in 60-80% of patients, and continence
improves in 35-60% of patients.
[0019] Perineal approaches have recurrence rates up to 50%, with
low morbidity. Incontinence and constipation improve in about 50%
of patients.
[0020] U.S. Pat. No. 6,706,057 discloses an applicator and method
for a perineal approach for treating hemorrhoids and concurrent
mucosal membrane rectal prolapses. The method comprises applying
compression sutures or staples to trap the tissue to be excised
distal to the anus, with subsequent excision of the prolapsed
tissue or hemorrhoid. Such treatment is less likely to be effective
for larger prolapses.
[0021] U.S. Pat. No. 6,332,888 discloses a method and apparatus for
treating rectal prolapse, the method comprising the step of
constricting the opening of the anus by applying sutures around the
opening. The sutures are applied using a finger-guided surgical
instrument with an ejectable substantially semi-circular needle.
Unfortunately, this type of treatment would appear to suffer all
the problems of using anal encirclement, including chronic
constipation problems.
[0022] There remains a need for safe and effective methods of
treating rectal prolapse.
SUMMARY OF THE INVENTION
[0023] The present invention includes surgical instruments and
implantable articles for treating rectal or pelvic muscle
prolapse.
[0024] The usual methods for surgically treating rectal prolapse
involve either perineal approaches or abdominal approaches. The
disclosed method, however, allows for the replacement of the
prolapsed rectum into its normal anatomic position without the need
for abdominal incisions. Instead, the posterior fascia of the
rectum is sutured to the fascia of the sacrum and coccyx via a
posterior vaginal incision (in females) or via a perineal incision
(in males). No abdominal incision is required, with no
scarring.
[0025] Another aspect of the present invention is specially adapted
instrumentation to facilitate the disclosed method of treating
rectal prolapse.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] A more complete appreciation of the invention and many of
the attendant advantages thereof will be readily obtained as the
same becomes better understood by reference to the following
detailed description when considered in connection with the
accompanying drawings, wherein:
[0027] FIG. 1 shows a rectal prolapse.
[0028] FIG. 2 shows a schematic view of a rectal prolapse.
[0029] FIG. 3 shows a prior art method of treating rectal prolapse,
the Marlex rectopexy.
[0030] FIG. 4 shows another prior art method of treating rectal
prolapse, the Altemeier procedure.
[0031] FIG. 5 shows a step in the disclosed method.
[0032] FIG. 6 shows an embodiment of the disclosed suturing
console.
[0033] FIG. 7 shows another view of the disclosed suturing console
and the disclosed method.
[0034] FIGS. 8 and 9 show another embodiment of the disclosed
device and method.
[0035] FIG. 10 shows an anchor modification of the disclosed method
and device.
[0036] FIG. 11 shows a device used to restore the rectum to its
natural geometry.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0037] Referring now to the drawings, wherein like reference
numerals designate identical or corresponding parts throughout the
several views. The following description is meant to be
illustrative only, and not limiting other embodiments of this
invention will be apparent to those of ordinary skill in the art in
view of this description.
[0038] As currently commonly practiced, a rectal prolapse,
illustrated in FIGS. 1 and 2, is repaired by attaching the rectum
to or about or near the sacrum, as shown in FIG. 3. Other methods
include resecting the exposed mass, as shown in FIG. 4.
[0039] The present method is an adaptation of the procedures
wherein the rectum is attached to the sacrum and coccyx. In an
embodiment of the invention, the patient is placed in a modified
dorsal lithotomy position with hips flexed and legs elevated in
stirrups. Vaginal retraction may be required. A posterior vaginal
incision is made, transversely across the vaginal apex, to create
access to the peritoneal cavity. (A perineal incision is made in
the male patient). The surgeon or an assistant then inserts his
finger into the rectum to feel the sacrum and coccyx. After
identifying these landmarks, a needle 3 is passed through the
vaginal (or perineal) incision and between the rectum 20 and the
sacrum 21 and coccyx 22, as shown in FIG. 5. Sutures attaching the
posterior rectal fascia to sacral fascia between the first and
second sacral vertebrae, between the second and third sacral
vertebrae, and between the fourth and fifth sacral vertebrae are
installed.
[0040] In an embodiment of the present invention, the method of
correcting prolapsed rectum is effected by using a specially
designed suturing console 1. Embodiments of the suturing console
are shown in FIGS. 6 and 7. As can be seen from the Figures, the
suturing console comprises a large modified needle 3. The large
modified needle 3 of the suturing console 1 may preferably be blunt
and can be of any shape, including curved or straight, as desired
for the efficiency of the procedure. The suturing console 1
includes within the modified needle 3 a suture 7 with an attached
sharp suturing needle 8. The end of the suture is situated near the
needle tip, with an outer spring 6 situated to prevent perforation
of the bowel while allowing suturing of the fascia by the sharp
suturing needle 8, which is attached to the distal end of the
suture 7. The sharp suturing needle 8 is preferable spring-like, to
facilitate placement of sutures. Troughs 9 may be located in the
protective outer spring 6 to allow for suturing with the sharp
suturing needle 8 and attached suture 7. In a preferred embodiment,
the suturing console 1 is placed in the proper location such that
the sutures 7 may be installed. Upon placement in the proper
location for attachment, the needle 3 with suture 7 is activated,
and sutures 7 are installed by the spring-like needle 3 with its
tip rotating through the sacral 21 and rectal fascia 20, with the
spring-like needle 3 extending through the troughs 9 located in the
protective outer spring 6. Upon proper placement, the end of the
suture 7 is held in place, the outer spring 6 is retracted, and the
suture 7 is cut and tied to secure the attachment of the sacral 21
and rectal fascia 20. This process is repeated twice more to allow
for additional suture attachment points. Upon completion of the
suturing process, the outer spring 6 and needle 3 are retracted
into the suturing console 1 and the console 1 is removed through
the vaginal incision.
[0041] In a preferred embodiment, the suturing console 1 comprises
a mechanism that allows for the activation of the sharp spring-like
suture needle 8 via controls 4 on the handle 2 of the suturing
console 1, such as buttons or similar controls.
[0042] In another embodiment of the present suturing console 1, the
suturing console 1 comprises a rectal tool 10 that has a tip 14, as
shown in FIGS. 8 and 9. The tool 10 is placed such that the tip 14
touches both the rectal 20 and sacral fascia 21. This allows for
better surgical understanding of the precise location of the
sutures 7. In such a preferred embodiment, the protective outer
spring 6 is not required. In a preferred embodiment, the tool 10
comprises a handle 11 and an attached tubular or housing structure
12 shaped and sized as appropriate for urogenital surgery. The
tubular or housing portion 12 encloses a suture 7 with an attached
sharp spring-like suture needle 13. The handle 11 may comprise some
mechanism, for control of the activation of the enclosed needle 13
and suture 7. Upon proper placement, the spring-like needle 13
extends from the tip of the tubular or housing portion 12 of the
rectal tool 10, and the needle 13 rotates through the rectal 20 and
sacral fascia 21. Upon proper placement, the end of the suture 7 is
held in place, the needle 13 is retracted into the tubular or
housing portion 12, the tubular or housing portion 12 is retracted,
and the suture 7 is cut and tied to secure the attachment of the
sacral 21 and rectal fascia 20. This process is may be repeated as
determined by the surgeon, in order to allow for additional suture
attachment points and increased stability. Upon completion of each
suture placement, the spring-like needle 13 is retracted into the
rectal tool 10. Repetition of the process on a contralateral side
of a patient may be desired, and is within the scope of the present
invention. Following completion of the suturing process, the tool
10 is removed through the vaginal (or perineal) incision.
[0043] In an embodiment of the above-described method, the suture
knots 15 are tied by any method known to the surgeon. Before tying
a knot 15 in the first suture 7, the suture 7 is held in place by a
clamp or hemostat 17 to allow for retraction of the spring-like
needle 13, which further allows for retraction of the suturing
console 1 or rectal tool 10 to place the next suture 7, as shown in
FIG. 9. In an alternative embodiment of the described devices and
method, a removable anchor 18 attached to suture 7 rests on the end
of the spring-like needle 13, as shown in FIG. 10. Upon placement
in a patient, the anchor eliminates the necessity for holding the
suture in place, as it will engage the suture with the tissue of
the patient sufficient to allow for retraction of the spring-like
needle, leaving such suture in place.
[0044] In a related embodiment, the suturing tool described herein
can be used for other pelvic and prolapse repairs and in connection
with hysterectomies and the like.
[0045] In a preferred embodiment of the present method, a rubber
device 19 shaped in the natural geometry of the rectum, as shown in
FIG. 11, is inserted in the prolapsed rectum 20 to assist in the
replacement of the prolapsed mass into its normal anatomic position
to allow suturing. This device may be of any shape and size as
required to return the rectum to its proper orientation and to
allow the fascia of the rectum 20 and sacral vertebrae 21 to be in
close proximity.
[0046] Obviously, numerous modifications and variations of the
present invention are possible in light of the above teachings. It
is therefore to be understood that within the scope of the appended
claims, the invention may be practiced otherwise than as
specifically described herein.
* * * * *